(24 days)
The intended use of the Eagle software for the Hologic QDR X-Ray Bone Densitometers is estimation of BMD.
The intended use of the Hologic Eagle Software Option is to estimate the projected bone mineral density (BMD, in g/cm2) and the Bone Mineral Content (BMC, in g) at various anatomical sites using the Hologic QDR® X-Ray Bone Densitometers.
The Eagle software operates with the Microsoft® Windows® 98 operating system and is a direct evolution from the software that is currently shipping with the QDR X-ray bone densitometers.
The Eagle software for the Hologic® QDR® X-Ray Bone Densitometers is intended for the estimation of Bone Mineral Density (BMD) and Bone Mineral Content (BMC) at various anatomical sites. The provided text, however, does not contain specific acceptance criteria or details of a study demonstrating how the device meets them. The document is a 510(k) summary and an FDA clearance letter, which confirm the device's substantial equivalence to a predicate device but do not typically include detailed study results or acceptance criteria.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method for the test set: This information is not present.
- If a multi-reader multicase (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This information is not present.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present.
- The type of ground truth used: This information is not present.
- The sample size for the training set: This information is not present.
- How the ground truth for the training set was established: This information is not present.
The document primarily states that the Eagle software is a direct evolution from existing software for Hologic QDR X-ray bone densitometers and is substantially equivalent to currently commercialized Hologic QDR X-Ray Bone Densitometers. The FDA clearance (K992677) confirms this substantial equivalence but does not provide the underlying performance study details.
{0}------------------------------------------------
Specical 510(K) - SUMMARY
Eagle Software for the HOLOGIC® QDR® X-Ray Bone Densitometers
| Submitter Name: | Hologic, Incorporated |
|---|---|
| Submitter Address: | 35 Crosby DriveBedford, MA 01730 |
| Contact Person: | Nandini Murthy, Regulatory Scientist |
| Phone Number: | (781) 999-7300 |
| Fax Number: | (781) 280-0662 |
| Date Prepared: | August 9, 1999 |
| Device Trade Name: | Eagle software for Hologic® QDR® X-Ray BoneDensitometers |
| Device Common Name: | X-Ray Bone Densitometer |
| Predicate Device: | Currently commercialized Hologic® QDR® X-Ray BoneDensitometers |
| Device Description: | The Eagle software operates with the Microsoft® Windows® 98operating system and is a direct evolution from the software thatis currently shipping with the QDR X-ray bone densitometers. |
| Intended Use: | The intended use of the Eagle software for the Hologic QDRX-Ray Bone Densitometers is estimation of BMD. |
- BMD = Bone Mineral Density
0012
{1}------------------------------------------------
ന 1999 SEP :
Ms. Nandini Murthy Regulatory Scientist Hologic, Inc. 35 Crosby Drive Bedford. MA 01730
Dear Ms. Murthy
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K992677 Eagle Software for Hologic® QDR® X-Ray Bone Densitometers Dated: August 9, 1999 Received: August 10, 1999 Product Code: 90 KGI Regulatory Class: II (two) 21 CFR 892.1170
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
BART D. U.S. Saito, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use Statement
The intended use of the Hologic Eagle Software Option is to estimate the projected bone mineral density (BMD, in g/cm2) and the Bone Mineral Content (BMC, in g) at various anatomical sites using the Hologic QDR® X-Ray Bone Densitometers.
Yamil h. Sezon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev, 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
ﺬ ﻋ
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.